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evercare inLine® MONOSET, 1-WAY, PVC Free, 180 cm
EUDAMEDClass IIa (EU MDR)
Ref 10515-01
Identity
- Trade Name
- evercare inLine® MONOSET, 1-WAY, PVC Free, 180 cm EUDAMED
- Device Name
- Monosets EUDAMED
- Model / Reference
- 10515-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06438129123579 EUDAMED
- Basic UDI-DI
- 6438129B0026HC EUDAMED
- EMDN Code
- A03010199 INFUSION CONTROLLERS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Sweden EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
evercare inLine® MONOSET, 1-WAY, PVC Free, 180 cm by OneMed Group Oy — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 6438129B0026HC | Class IIa | Active |
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Manufacturer
- Manufacturer
- OneMed Group Oy
- EUDAMED SRN
- FI-MF-000000642
Sources (2)
- EUDAMED 7fd9f0cf-7cb0-4bf5-b08c-7ee59ec67a57 61 fields · synced Jun 19, 2026
- EUDAMED 9dcf88a0-5cdc-4e55-ab61-c27cc26b2ed5 61 fields · synced Jun 19, 2026